Safety and Efficacy Study of rhAngiostatin Administered in Combination With Paclitaxel and Carboplatin to Patients With Non-Small-Cell Lung Cancer

This study has been completed.

First Received: November 13, 2002 Last Updated: January 8, 2009 History of Changes

Sponsored by:	EntreMed
Information provided by:	EntreMed
ClinicalTrials.gov Identifier:	NCT00049790

Purpose

The purpose of this study is to determine the safety and efficacy of rhAngiostatin protein administered in combination with paclitaxel and carboplatin to patients with non-small-cell lung cancer.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: recombinant human Angiostatin protein Drug: paclitaxel Drug: carboplatin	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by EntreMed:

Estimated Study Completion Date:

December 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Histological or cytological confirmed Stage IIIB NSCLC with malignant pleural effusions, or Stage IV NSCLC or recurrent NSCLC
No previous chemotherapy for NSCLC
Have one lesion that is bidimensionally measurable by physical exam, MRI, or CT greater than 1 cm in diameter
Specified lab parameters
Life expectancy of at least 12 weeks
ECOG performance status of 0 or 1
Understand requirements of study
Agree to use effective contraceptive methods

Exclusion:

Have CNS metastases
Have any active cancer in addition ot NSCLC
Participated in clinical trial involving conventional or investigational drugs within previous 4 weeks
Have any contraindication to paclitaxel or carboplatin
Have had Grade 3 or greater peripheral neuropathies
Be pregnant or lactating
Have a history of myocardial infarction or angina pectoris/angina in the last 6 months
Have had significant (30 mL or more) hemoptysis with the past 3 months
Have an active infection
Have a history of bleeding diathesis, hypercoagulable condition, or an active bleeding disorder
Be receiving concurrent treatment with therapeutic doses of heparin or coumadin
Have had major surgery within 4 weeks of stating therapy
Have additional uncontrolled serious medical conditions or psychiatric illness
Received rhAngiostatin in other clinical protocols

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049790

Locations

United States, Indiana
Indiana Cancer Pavilion, Indiana University
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

EntreMed

More Information

No publications provided

Study ID Numbers:	ANG-CL-004
Study First Received:	November 13, 2002
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00049790 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by EntreMed:

Advanced non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carboplatin
Antimitotic Agents
Angiogenesis Inhibitors
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel

Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Angiostatins
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
Mitosis Modulators

Carboplatin
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Angiostatins
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009